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SAXENDA (nda206321)- (18MG/3ML (6MG/ML))

LIRAGLUTIDE NOVO
18MG/3ML (6MG/ML)
Yes No
3026-Aug-03 2015-Jan-25
None 2017-Jan-25
None No
SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Adult patients with an initial body mass index (BMI) of • 30 kg/m2 or greater (obese), or • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia). Pediatric patients aged 12 years and older with: • body weight above 60 kg and • an initial BMI corresponding to 30 kg/m2 for adults (obese) by international cut-offs.
0 0 0
Total Other Developers 25
Drugs with Suitability No
18MG/3ML (6MG/ML) ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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